1. Field of the Invention
The present invention relates to a wireless monitoring system and, more particularly, to a wireless electrocardiograph (ECG) system, along with method of use for interactively detecting and analyzing patient's cardiovascular activity and downloading updated algorithms that are best suited for patients condition. This invention includes, but is not limited to, the continuous ECG monitoring of patients in an outpatient setting, utilizing a multi-stage analysis method and a special diagnostic reporting data buffer.
2. Description of Prior Art
ECG systems are used for monitoring activity of a patient's heart. A number of electrodes are positioned on the patient. Wires are connected from the electrodes to an ECG monitor. The ECG monitor processes the signals and outputs ECG data, in form of traces representing activity of the heart by measuring electrical signals at different positions on the patient.
Several classes of ECG monitoring devices are presently available in the market. Each of these devices exhibits major issues and limitations that the current invention resolves.
Stand-alone ECG monitoring systems are used to monitor and record patient's cardiovascular activity within a hospital or clinic and display or print the resulting waveforms for doctor's viewing. The problems associated with such devices are numerous. One fundamental problem is that the wires of these devices inhibit movement by and around the patient. Because the patient is wired to the stationary ECG device, doctors must work around the wires to gain access to the patient. Additionally, the patient cannot move freely and/or must always be accompanied by all the wires and equipment whenever the patient leaves the hospital bed. Another problem with these devices is that the wires will stress the electrodes connecting the patient to the stand-alone ECG device, resulting in malfunction or disconnection between the patient and the ECG device. Additionally, such stand-alone ECG devices are not suited for outpatient and post care applications. The devices are large and bulky and are not portable or designed for in-home care. In addition, current stand-alone ECG devices lack the flexibility to adapt themselves automatically to each patient's cardiovascular condition by interactively uploading new algorithms and software parameters for a more effective arrhythmias and other abnormal heart conditions analysis. Such devices require manual input by the care provider and are incapable of adapting themselves on-the-fly during cardiovascular monitoring process.
There are portable ECG monitoring devices that exist in several configurations that do not connect the patient to an external stand-alone device. However, these, like their stand-alone counterparts have numerous shortcomings. Many of the prior art portable ECG monitoring devices are intended to be recording devices only. These devices record cardiovascular data over long periods of time for later viewing and analysis. Additionally, these devices are incapable of performing any type of analysis of the patient's cardiovascular condition. These devices are not interactive and are not remotely programmable. An example of such devices is the ubiquitous Holter ambulatory ECG monitor. This device is worn typically around the neck of the patient and is about the size of a tape recorder. From the bottom of the Holter monitor are several wires, generally five, that attach to electrodes that are placed about the patient's torso by sticky pads. Holter monitors continuously record a patient's ECG waveform over an extended period of time such as a 24-hour period or several weeks. These devices often contain a large storage memory for recording the patient heart waves over these long time periods. The patient carries the complete monitor and recorder. The Holter ECG devices record the cardiovascular data only; they cannot scrutinize the data, they merely save it for the primary care physician to review later. The data recorded by a Holter monitor is known and can be analyzed only after the recording period is over; therefore, if the patient experiences an abnormality, the Holter device is incapable of performing an immediate analysis or of assisting the patient by interactively communicating with a doctor. Additionally, Holter monitors lack the processing power and the necessary software algorithms to immediate analyze the ECG data.
There are also portable ECG monitors that are not worn by the patient for extended time periods. These ECG monitors are hand-held monitoring devices that monitor and record for relatively short periods of time, typically a 30-minute interval, performed several times a day. A major problem with these devices is that there is a stored history of only that which was recorded. If the patient experiences a cardiovascular abnormality there is no record of it unless the patient was coincidentally recording at that moment. Additionally, these devices are not designed for extended wear and do not have a sufficient memory to record for extended times, like days and weeks on end. Nor do these devices have the battery life to sustain the monitors for such extended time periods. These devices are capable of only a very limited and generic analysis and are not able to interactively upload/download algorithms or software commands to adapt themselves to the patient's cardiovascular monitoring needs.
Additionally, among the portable extended-wear ECG monitoring devices, there are devices that store the recorded heart information and are capable of transmitting that information wirelessly, to a local base station which relays the ECG data by phone to a diagnostic center where it can be promptly scrutinized for arrhythmias. However, this method constrains the normal daily activities of the patient, as the patient must continually stay within range of the local base station. Additionally, these devices don't perform any analysis nor are they programmable or adaptable to the patient's unique monitoring needs. Of those devices that are capable of some sort of analysis, such analysis is very limited and fixed. They cannot do any in-depth analysis and because they have fixed programs, they cannot upload or download software and algorithms that customize the detection, analysis and reporting for the patient's unique and individual needs. Another inadequacy with such wireless ECG monitoring devices is their limited processing power. These small wireless ECG monitoring devices are further restricted by being able to perform a limited number of complex computations on the captured cardiovascular data, in their analysis of the data for arrhythmias and other abnormal heart conditions. The inability to perform more analysis means that these devices take a one-size-fits-all approach to their cardiovascular analysis and detection of abnormalities. Additionally, their limited battery life poses another obstacle, since due to their small battery size and extended recording requirement, the battery life is very limited, which directly prohibit the more powerful processors from conducting complex computations over extended time periods. Also, lack of flexibility further limits the capability of such wireless ECG monitoring devices. Current wireless ECG devices are not able to adapt themselves automatically to each patient's cardiovascular condition by interactively uploading new algorithms and software parameters for a more effective cardiovascular abnormality analysis.
What is needed is an ECG device that has the capability to record the patient cardiovascular activity over extended time period such as a 24-hour period or longer in conjunction with the ability to transmit the recorded data automatically or on-demand to an outside wireless computing device. Furthermore, there is a significant need for a wireless ECG monitoring device that is capable of analyzing and scrutinizing the patient's cardiovascular data for arrhythmia and other abnormal heart conditions. Also, in the event that abnormal activity or activities are detected, there is a significant need for an ECG monitor that can transmit recent history packets of the patient's cardiovascular activity prior to and including each abnormal event to a wireless computing device for doctor's viewing and further analysis. A wireless ECG device needs to also be able to adapt its internal algorithms for analyzing the recorded data to each patient's unique requirements by means of uploading additional software algorithms and computational parameters interactively from an outside wireless computing device such as a mobile phone, tablet-PC or laptop computer. Finally, because of its limited processing power and battery-life, a wireless ECG monitoring device also needs to be able to automatically tap into the superior processing power of an external computing device, thru wireless communications. The present invention provides all of the above capabilities and corrects the deficiencies of the prior art.